Low-Profile Single and Dual Vascular Access Device

ABSTRACT

A low-profile access port for subcutaneous implantation within a patient. The access port can include a set of receiving cups which can be placed in fluid communication with a catheter. The set of receiving cups can provide a greater skin surface with which to access the port to avoid repeated penetrations at a single locus, such as during consecutive dialysis treatments. The access port can alternatively include needle penetrable arms or elongate chambers that also have a slim, low profile. The access port can include a needle guide to direct subsequent needle access to different insertion points to permit healing at the previous insertion points. The access port can be formed of a modular construction with a first conduit, a second conduit, and an outer shell. The outer shell can include a proximal portion and a distal portion. The access port can include a stem assembly and a locking member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.16/382,177, filed Apr. 11, 2019, now U.S. Pat. No. 11,464,960, whichclaims the benefit of U.S. Provisional Application No. 62/657,662, filedApr. 13, 2018, and U.S. Provisional Application No. 62/732,928, filedSep. 18, 2018, and which is a continuation-in-part of U.S. patentapplication Ser. No. 15/809,879, filed Nov. 10, 2017, now U.S. Pat. No.11,420,033, which claims the benefit of U.S. Provisional Application No.62/421,131, filed Nov. 11, 2016, and U.S. Provisional Application No.62/552,681, filed Aug. 31, 2017, and which is a continuation-in-part ofU.S. patent application Ser. No. 14/162,113, filed Jan. 23, 2014, nowU.S. Pat. No. 10,463,845 which claims the benefit of U.S. ProvisionalApplication No. 61/755,913, filed Jan. 23, 2013. Each of theaforementioned applications is incorporated by reference in its entiretyinto this application.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa low-profile access port for subcutaneous implantation within the bodyof a patient. The access port includes a receiving cup that provides arelatively large subcutaneous target to enable a catheter-bearing needleto access the port without difficulty. In addition, the access portincludes a valve/seal assembly to permit pressurized fluid injectionthrough the port while preventing backflow.

In an aspect of the invention a device is provided that allows immediatesubcutaneous dialysis access while allowing patients to bathe andshower. Such a device reduces costs and time associated with cleaningand maintenance relative to traditional tunneled dialysis catheterpositioned external to the body.

In an aspect of the invention, a device is provided enabling long-termdialysis while minimizing skin trauma. Typical infusion or apheresisport interfaces forces a clinician to access the approximately the samelocus every time the port is accessed. Dialysis is typically requiredmultiple times per week. Embodiments of an implantable dialysis port isprovided that allows for multiple needle insertion sites, therebyreducing trauma to a single locus on the skin.

In an aspect of the invention, a low-profile access port comprises abody including a conduit with an inlet port at a proximal end thereof,and a receiving cup. The receiving cup is concavely shaped to direct acatheter-bearing needle into the conduit via the inlet port. Thereceiving cup is oriented substantially toward a skin surface whensubcutaneously implanted within the patient to ease needle impingementthereon. A valve/seal assembly disposed in the conduit enables passageof the catheter therethrough while preventing fluid backflow.

In an aspect of the invention, a low-profile access port forsubcutaneous implantation within the patient is disclosed and comprisesa body including a conduit with an inlet port at a proximal end thereof,and a receiving cup. The receiving cup is funnel shaped to direct acatheter-bearing needle into the conduit via the inlet port. The conduitis defined by the body and extends from the inlet port to an outletdefined by a stem. A bend in the conduit enables catheter advancementpast the bend while preventing needle advancement. A valve/seal assemblyis also disposed in the conduit and enables passage of the cathetertherethrough while preventing fluid backflow. The body includesradiopaque indicia configured to enable identification of the accessport via x-ray imaging.

In an aspect of the invention, a low-profile access port is disclosedand comprises a body including a first set of receiving cups, a firstset of inlet ports, each receiving cup of the first set of receivingcups in fluid communication with an inlet port of the first set of inletports, each receiving cup concavely shaped to direct an impinging needletoward the inlet port. A first conduit in fluid communication with eachinlet port of the first set of inlet ports, the first conduit extendingfrom the first set of inlet ports to a first outlet of a port stem and acatheter in fluid communication with the first outlet.

In some embodiments, a second set of receiving cups are in fluidcommunication with an inlet port of the second set of inlet ports, and asecond conduit in fluid communication with each inlet port of the secondset of inlet ports, the second conduit extending from the second set ofinlet ports to a second outlet of the port stem. The first set ofreceiving cups are proximal to the second set of receiving cups. Aperimeter of each receiving cup of the first set of receiving cups liesin a plane, and wherein the plane of the perimeter of each receiving cupis angled with respect to one another. A perimeter of each receiving cupof the first set of receiving cups lies in a plane, and wherein theplane of the perimeter of each receiving cup is co-planar with respectto one another. A perimeter of each receiving cup of the first set ofreceiving cups includes a cutout, the cutout between adjacent receivingcups providing communication therebetween.

In an aspect of the invention, a dialysis catheter assembly is disclosedand comprises a catheter having a first lumen and a second lumen, abifurcation hub having a distal end in communication with a proximal endof the catheter, a first extension leg and a second extension legconnected to a distal end of the bifurcation hub, the first extensionleg in fluid communication with the first lumen, the second extensionleg in fluid communication with the second lumen. A first port includinga first receiving cup defining a first perimeter substantially parallelto the skin surface following implantation of the dialysis catheterassembly, the first port including a first outlet in fluid communicationwith the first receiving cup, the first outlet in fluid communicationwith the first extension leg. A second port separated from the firstport, the second port including a second receiving cup defining a secondperimeter substantially parallel to the skin surface followingimplantation of the dialysis catheter assembly, the second portincluding a second outlet in fluid communication with the secondreceiving cup, the second outlet in fluid communication with the secondextension leg.

In some embodiments, the first receiving cup includes a first septumcovering the first perimeter, and the second receiving cup includes asecond septum covering the second perimeter, the first septum and thesecond septum providing a continuous outer profile to the first port andthe second port.

In an aspect of the invention, a subcutaneous dialysis port is disclosedand comprises, a catheter having a first lumen and a second lumen, abifurcation hub having a distal end in communication with a proximal endof the catheter. A first elongate arm and a second elongate armconnected to a distal end of the bifurcation hub, the first elongate armin fluid communication with the first lumen, the second elongate arm influid communication with the second lumen, each of the first elongatearm and the second elongate arm including a needle penetrable portion inan upper wall thereof.

In some embodiments, a lower wall of the first elongate arm and thesecond elongate arm are formed of a compliant material that allows thefirst and second elongate arm to conform to a contour of a patient'sbody. The first elongate arm and the second elongate arm each include anend cap disposed at the proximal end thereof, each end cap including atleast one of a palpation feature and an indicia, the indicia observableunder a suitable imaging modality. The at least one of the palpationfeature and the indicia indicating a flow direction to a user. Theneedle penetrable portion includes a self-sealing silicone material. Alower wall of the first elongate arm and the second elongate arm areformed of a needle impenetrable material.

In an aspect of the invention, a vascular access device for subcutaneousimplantation is disclosed and comprises a catheter having a first lumenand a second lumen, an elongate body defining a first elongate chamberand a second elongate chamber, the first elongate chamber in fluidcommunication with the first lumen and the second elongate chamber influid communication with the second lumen. A needle penetrable septum isdisposed over an opening in an upper surface of the elongate body, theopening providing access to the first elongate chamber and the secondelongate chamber. A needle impenetrable guide disposed over the openingand the needle penetrable septum, the needle impenetrable guideincluding a plurality of first openings positioned over the firstelongate chamber, and a plurality of second openings positioned over thesecond elongate chamber.

In some embodiments, the elongate body has a length and a width, thelength more than two times greater than the width. The first elongatechamber and the second elongate chamber extend in a side-by-sidearrangement relative to a longitudinal axis of the elongate body. Thefirst elongate chamber and the second elongate chamber are in a tandemarrangement relative to a longitudinal axis of the elongate body suchthat the first elongate chamber is proximal to the second elongatechamber. The impenetrable needle guide is disposed at least partiallywithin the needle penetrable septum. The impenetrable needle guide doesnot penetrate the needle penetrable septum. The plurality of firstopenings are parallel to the plurality of second openings.

In an aspect of the invention, a port assembly is disclosed comprising afirst conduit including a first receiving cup at a proximal end and afirst nozzle at a distal end, wherein a first valve assembly is disposedbetween the first receiving cup and the first nozzle. A second conduitincluding a second receiving cup at a proximal end and a second nozzleat a distal end, wherein a second valve assembly is disposed between thesecond receiving cup and the second nozzle. An outer shell surroundingthe first conduit and the second conduit, the outer shell including aproximal portion surrounding the first receiving cup and the secondreceiving cup, and the distal portion surrounding the first nozzle andthe second nozzle, the proximal portion, the distal portion, the firstconduit, and the second conduit connected via press fit engagement.

In some embodiments, the distal portion of the outer shell includes adistal receiving slot designed to receive a stem assembly. The stemassembly includes a housing having a proximal end designed for insertioninto the distal receiving slot, and wherein the stem assembly isconnected to the distal portion of the outer shell via press fitengagement. The stem assembly includes a first stem and a second stemextending from a distal end of the housing, the first stem in fluidcommunication with the first receiving cup, and the second stem in fluidcommunication with the second receiving cup. The port assembly furthercomprising a catheter including a first lumen designed for insertionover the first stem, a second lumen designed for insertion over thesecond stem, and a locking member designed to couple the stem assemblyto the catheter. The stem assembly includes a first slot on an upperportion and a second slot on a lower portion, and wherein the lockingmember includes a first protrusion designed to snap-fit in the firstslot, and a second protrusion designed to snap-fit in the second slot.The outer shell, the housing, and the locking member together provide asmooth continuous outer surface.

In light of the above, embodiments herein are generally directed to avascular access device, also referred to herein as an access port, forsubcutaneous implantation within the body of a patient. The implantedaccess port is transcutaneously accessible by a catheter-bearing needle,such as a peripheral intravenous (“Hy”) catheter, so as to place the PIVcatheter into fluid communication with the access port. A fluid outletof the access port is operably connected to an in-dwelling catheterdisposed within the vasculature of a patient, in one embodiment, toenable the infusion into and/or removal of fluids from the patient'svasculature to take place via the PIV catheter.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1E show various views of an access port according to oneembodiment;

FIG. 2 is a cross sectional view of the access port of FIGS. 1A-1E;

FIG. 3A-3C are various views of a low-profile access port according toone embodiment;

FIG. 4 is a top view of a low-profile access port according to oneembodiment;

FIG. 5 is a perspective view of a low-profile access port according toone embodiment;

FIG. 6 is a perspective view of a low-profile access port according toone embodiment;

FIGS. 7A and 7B are various views of an access port according to oneembodiment;

FIGS. 8A and 8B are various views of an access port according to oneembodiment;

FIGS. 9A-9G depict various views of a low-profile vascular access deviceaccording to one embodiment;

FIG. 10 is an exploded view of the access device of FIGS. 9A-9G;

FIG. 11 is a cross-sectional view of the access device of FIGS. 9A-9G;

FIGS. 12A-12C depict various views of a seal according to oneembodiment;

FIGS. 13A-13C depict various views of a valve according to oneembodiment;

FIGS. 14A-14D depict various stages of insertion of a catheter into theaccess device of FIGS. 9A-9G;

FIGS. 15A and 15B depict various views of a guide device for use withthe access device of FIGS. 9A-9G according to one embodiment;

FIGS. 16A-16G depict various views of a low-profile vascular accessdevice according to one embodiment;

FIGS. 17A and 17B depict various views of the vascular access port ofFIGS. 16A-16G;

FIG. 18 is an exploded view of the vascular access device of FIGS.16A-16G;

FIG. 19 is a partially transparent view of the vascular access device ofFIGS. 16A-16G;

FIG. 20 is a perspective view of a portion of the vascular access deviceof FIGS. 16A-16G;

FIGS. 21A and 21B are cutaway views of the vascular access device ofFIGS. 16A-16G;

FIGS. 22A-22C depict various views of a low-profile vascular accessdevice according to one embodiment;

FIG. 23 is a partially transparent view of the vascular access device ofFIGS. 22A-22C;

FIG. 24 is a partially transparent view of a portion of the vascularaccess port of FIGS. 22A-22C;

FIGS. 25A-25E depict various views of a low-profile vascular accessdevice according to one embodiment;

FIGS. 26A-26D depict various views of a low-profile vascular accessdevice according to one embodiment;

FIG. 27 is a cross-sectional view of a valve/seal configurationaccording to one embodiment;

FIG. 28 is a cross-sectional view of a valve/seal configurationaccording to one embodiment;

FIG. 29 is a cross-sectional view of a valve/seal configurationaccording to one embodiment;

FIG. 30 is a cross-sectional view of a valve/seal configurationaccording to one embodiment;

FIG. 31 is a perspective view of a portion of a vascular access deviceaccording to one embodiment;

FIGS. 32A-32B depict perspective views of a low-profile vascular accessdevice according to one embodiment;

FIG. 33 depict a perspective view of a low-profile vascular accessdevice according to one embodiment;

FIGS. 34A-34B depict perspective views of a low-profile vascular accessdevice according to one embodiment;

FIGS. 35A-35J depict various views of a low-profile vascular accessdevice according to one embodiment;

FIG. 36A depict a perspective view of a low-profile vascular accessdevice according to one embodiment;

FIG. 36B depicts an exploded view of a low-profile vascular accessdevice according to one embodiment;

FIG. 37A depicts a perspective view of a port assembly of the device ofFIG. 36A;

FIG. 37B depicts an exploded view of the port assembly of FIG. 37A;

FIGS. 38A-38B depict various views of the catheter of the device of FIG.36A; and

FIGS. 39A-39C depict various views of the connector of the device ofFIG. 36A.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to an accessport for subcutaneous implantation within the body of a patient. Theimplanted access port is transcutaneously accessible by acatheter-bearing needle, such as a peripheral intravenous (“PIV”)catheter, so as to place the PIV catheter into fluid communication withthe access port. A fluid outlet of the access port is operably connectedto an in-dwelling catheter disposed within the vasculature of a patient,in one embodiment, to enable the infusion into and/or removal of fluidsfrom the patient's vasculature to take place via the PIV catheter, e.g.dialysis or similar extracorporeal treatment.

In accordance with one embodiment, the access port defines a low profileso as to facilitate ease of placement within the subcutaneous tissue ofthe patient. Further, the access port is configured to provide arelatively large subcutaneous target to enable the PIV catheter or othersuitable catheter-bearing needle to access the port without difficulty.In addition, the access port includes a valve/seal assembly to permitthe injection of fluids through the access port at a relatively highflow rate, such as about 5 ml per second at a pressure of about 300 psi(also referred to herein as “power injection”). Possible applicationsfor the access port described herein include administration ofmedicaments and other fluids to the patient, pheresis/apheresis/dialysisor similar extracorporeal treatments that enable fluid to be infusedinto or removed from the patient's vasculature, fluid aspiration, etc.

Reference is first made to FIGS. 1A-1E, which show various details of anaccess port, generally designated at 10, in accordance with oneembodiment. As shown, the port 10 includes a body 12 that is defined inthe present embodiment by a first portion 12A and a second portion 12B(FIG. 1E). In the present embodiment the port body 12 includes a metalsuch as titanium, and as such, the second portion 12B is press fit intoengagement with the first portion 12A to define the body, though it isappreciated that the port body can include a variety of other materials,including metals, thermoplastics, ceramics, etc.

The port body 12 defines in the present embodiment a substantiallyconcavely-shaped receiving cup 14 for receiving and directing acatheter-bearing needle (FIG. 2 ) to operably connect with the port 10,as described further below. In particular, the substantially concaveshape of the receiving cup 14 is configured to direct a catheter-bearingneedle (FIG. 2 ) impinging thereon toward an inlet port 16 that servesas an opening for a conduit 18 defined by the port body 12. The open andshallow nature of the receiving cup 14 together with its substantiallyupward orientation (i.e., toward the skin surface of the patient), sothat it is substantially parallel to the skin surface whensubcutaneously implanted under the skin of the patient (i.e., thereceiving cup is substantially parallel to the skin surface when theskin is at rest, or undeformed by digital pressure or manipulation),enables the receiving cup to present a large, easily accessible targetfor the needle when introduced into the skin, as seen in FIG. 2 . FIG. 2further shows that the port 10 defines a relatively low profile height,which enables relatively shorter needle lengths to be used for accessingthe port after implantation. It will be appreciated that the port 10,port body 12, funnel 14, portions thereof, or the like, can beconstructed of a suitable biocompatible material. Further, the port 10,or portions thereof can include metals, for example titanium. Suchmetals can be biocompatible, radiopaque, and/or resistant to gougingfrom an impinging needle, as will be discussed in more detail herein. Byway of example, the port 10, port body 12, funnel 14, portions thereofthat include titanium, can be machined, can be formed byinjection-molding powdered titanium, or manufactured via other suitablemethods.

Palpation features 26 are included with the port body 12 to assist aclinician to locate and/or identify the port 10 via finger palpationafter implantation under the skin of the patient. In detail, thepalpation features 26 in the present embodiment include a bump 26Adisposed near the proximal end of the receiving cup 14 and a ridge 26Bdisposed above and curving around a distal portion of the receiving cup.FIG. 1B shows that the palpation features extend above the general upperplane defined by the port 10 so as to facilitate palpation of thefeatures by a clinician in order to locate the position and/ororientation of the receiving cup 14. Note that a variety of other sizes,configurations, numbers, etc., of palpation features can be included onthe port in addition to what is shown and described herein.

A guide groove 28 is defined on the receiving cup 14 and islongitudinally aligned with the inlet port 16 of the conduit 18. Theguide groove 28 is defined as a depression with respect to adjacentportions of the surface of the receiving cup 14 and extends distallyalong the receiving cup surface from a proximal portion of the receivingcup so as to provide a guide path to guide the distal tip of thecatheter-bearing needle toward the inlet port 16 once impingement of theneedle into the guide groove is made. This in turn reduces the chancethe needle will slide across and off the receiving cup 14 duringinsertion. Note that these and other similar features, though differingin shape and configuration, can also be included on the other portsdisclosed herein.

As best seen in FIG. 1E, the port body 12 further defines the conduit 18as a pathway into which a transcutaneously inserted catheter can pass soas to place the catheter in fluid communication with the port 10. Asshown, the conduit 18 is in communication with the receiving cup 14 viathe inlet port 16. A first conduit portion 18A of the conduit 18distally extends from the inlet port 16 in an angled downward directionfrom the perspective shown in FIG. 1E to a bend 30, where a secondconduit portion 18B of the conduit angles slightly upward and changesdirection at a predetermined angle θ₁. Note that angle orientation θ₁ inone embodiment is about 37 degrees, but can vary from this in otherembodiments, including angles less than 37 degrees in one embodiment.The magnitude of angle θ₁ depends in one embodiment on various factors,including the size of the catheter and/or needle to be inserted into theport conduit, the size of the conduit itself, etc.

The conduit 18 then extends to and through a cavity 20A defined by avalve housing 20 of the port body. The conduit 18 extends to a distalopen end of the stem 24 of the port 10. The conduit 18 is sized so as toenable the catheter 40 (FIG. 2 ) to pass therethrough, as will be seen.

As mentioned, the valve housing 20 defines a cavity 20A through whichthe conduit passes and which houses a valve/seal assembly 22. Thevalve/seal assembly 22 includes a sealing element, or seal 32, whichdefines a central hole through which the catheter 40 can pass, a firstslit valve 34A and a second slit valve 34B. The seal 32 and valves 34A,34B are sandwiched together in one embodiment and secured in placewithin the cavity 20A as shown in FIG. 1E. The slits of the slit valves34A, 34B are rotationally offset from one another by about 90 degrees inthe present embodiment, though other relationships are possible.

The seal 32 and valves 34A, 34B of the valve/seal assembly 22 cooperateto enable fluid-tight passage therethrough of the catheter 40 (FIG. 2 )while also preventing backflow of fluid through the valve/seal assembly.Indeed, in one embodiment the seals disclosed herein prevent fluid flowaround the external portion of the catheter when the catheter isdisposed through the seal, while the valves are suitable for preventingfluid flow when no catheter passes through them. As such, when thecatheter 40 is not inserted therethrough the valve/seal assembly 22seals to prevent passage of air or fluid. In the present embodiment, theseal 32 and valves 34A, 34B include silicone, though other suitablycompliant materials can be employed.

The port 10 in the present embodiment includes an overmolded portion 36that covers the port body 12. The overmolded portion 36 includessilicone or other suitably compliant material and surrounds the body 12as shown so as to provide a relatively soft surface for the port 10 andreduce patient discomfort after port implantation. The overmoldedportion 36 includes two predetermined suture locations 38, best seen inFIG. 1C, for suturing the port 10 to patient tissue, though sutures maybe passed through other portions of the overmolded portion, if desired.The overmolded portion 36 further defines a relatively flat bottomsurface 36A so as to provide a stable surface for the port 10 in itsposition within the tissue pocket after implantation. In contrast, theport shown in FIG. 3C includes a bottom surface with a slightly roundedprofile.

FIG. 2 depicts details regarding the insertion of the catheter 40disposed on the needle 42, according to one embodiment. After locatingthe port 10 via through-skin palpation of the palpation features 26, aclinician uses the catheter-bearing needle 42 to pierce a skin surface44 and insert the needle until a distal tip 42A thereof impinges on aportion of the receiving cup 14, as shown. Note that, because of theorientation of the receiving cup 14 as substantially parallel to theskin surface, the needle 42 can impinge on the receiving cup at aninsertion angle θ₂ that is relatively steep, which facilitates ease ofneedle insertion into the body. Indeed, in one embodiment a needleinserted substantially orthogonally through the skin of the patient canimpinge the receiving cup of the access port.

The needle 42 is manipulated until the distal tip 42A is received intothe guide groove 28, which will enable the distal tip to be guided alongthe groove to the inlet port 16. The needle 42 is then inserted throughthe inlet port 16 and into the first portion 18A of the conduit 18 untilit is stopped by the bend 30. The needle 42 can then be proximallybacked out a small distance, and the catheter 40 advanced over theneedle such that the catheter bends and advances past the bend 30 intothe second portion 18B of the conduit 18. Catheter advancement continuessuch that a distal end 40A of the catheter 40 advances into and past thehole of the seal 32 and through both slits of the slit valves 34A, 34Bof the valve/seal assembly 40. Once the distal end 40A of the catheter40 has extended distally past the valve/seal assembly 22, furtheradvancement can cease and fluid transfer through the catheter 40 andport 10 can commence, including infusion and/or aspiration through thestem 24. Once fluid transfer is completed, the catheter 40 can bewithdrawn proximally through the valve/seal assembly 22 and the conduit,then withdrawn through the surface 44 of the skin and out of thepatient.

FIGS. 3A-3C depict details of an access port 110 according to anotherembodiment. Note that various similarities exist between the port 10 andthe other ports shown and described herein. As such, only selected portaspects are discussed below. As shown, the port 110 includes a body 112that in turn includes a first body portion 112A and a second bodyportion 112B, best seen in FIG. 3C. The body 112 in the presentembodiment includes a thermoplastic, such as an acetyl resin in thepresent embodiment. As such, the first and second body portions 112A,112B are ultrasonically welded to one another to define the body 12, inthe present embodiment. As before, a receiving cup 114 is included withthe body 112 and is operably connected to a conduit 118 via an inletport 116. Also, note that a variety of materials can be used to definethe port body, receiving cup, conduit, etc.

A valve/seal assembly 122 is disposed within a cavity 120A that isdefined by a valve housing 120, which in the present embodiment, isdefined by the first body portion 112A. The valve/seal assembly 122includes a proximal seal 132 with a central hole for catheter passage,two slit valves 134A, 134B each with a slit arranged at a 90-degreeoffset with respect to the other, and a distal seal 135 with a centralhole, also referred to herein as a sphincter seal.

The distal seal 135 includes on its distal surface a frustoconicalportion 135A disposed about the seal central hole that is configured toprovide a sphincter-like seal about the outer surface of a catheter whenit extends through the valve/seal assembly. The frustoconical portion135A is disposed such that any back-flowing fluid impinging on thefrustoconical portion will cause the seal to secure itself about theouter surface of the catheter in an even tighter engagement, thuspreventing backflow past the catheter outer surface when high fluidpressures are present, such as in the case of power injection. Asmentioned, other valve/seal combinations can also be included in thevalve/seal assembly.

In the present embodiment, the receiving cup 114 and portion of theconduit 118 proximal to the valve/seal assembly 122 both include aneedle-impenetrable lining that prevents the distal end of a needle fromgouging the surface when impinging thereon. This, in turn, prevents theundesirable creation of material flecks dug by the needle. Varioussuitable materials can be employed for the needle-impenetrable material,including glass, ceramic, metals, etc. In one embodiment, the componentsof the port 110 are all non-metallic such that the port is consideredMM-safe, by which the port does not produce undesired artifacts in MRIimages taken of the patient when the port is in implanted therewithin.

FIG. 4 depicts additional features of the port 110 according to anotherembodiment. As shown, in the present embodiment the receiving cup 18includes radiopaque indicia 128 to indicate a characteristic of the port110. Here, the radiopaque indicia 128 includes a “C” and a “T” that areformed by a radiopaque material, such as tungsten, bismuth trioxide,etc., so as to be visible after port implantation via x-ray imagingtechnology. For instance, the radiopaque material can be formed as aninsert that is insert-molded included in the port body, as an initiallyflowable material that is injected into a cavity of the port body beforehardening, etc. In embodiments where the port body is metallic, theradiopaque indicia can be formed by etching, engraving, or otherwiseproducing a relative thickness difference between the indicia and thesurrounding port body material so as to produce an x-ray-discerniblecontrast that shows up in an x-ray image.

In the present embodiment, the CT radiopaque indicia 128 indicate to anobserver that the port is capable of power injection of fluidstherethrough. In addition to this characteristic, other characteristicscan be indicated by various other types of indicia as appreciated by oneskilled in the art.

Further, in the present embodiment the top view of the port 110 of FIG.4 indicates that the port body 112 in the region surrounding thereceiving cup 114 defines a generally triangular shape, which can bepalpated by a clinician after implantation and can indicate not only thelocation of the receiving cup, but also a particular characteristic ofthe port, such as its ability to be used for power injection. Of course,the receiving cup may define shapes other than triangular in otherembodiments.

FIG. 4 further shows that distributed about the perimeter of thereceiving cup 114 are three palpation features 126, namely, three sutureplugs 126A disposed in corresponding holes defined in the port body 112.The suture plugs 126A include raised silicone bumps in the presentembodiment and can serve to locate the position of the receiving cup 114post-implantation when they are palpated by a clinician prior to needleinsertion into the patient. Various other palpation features could beincluded with the port, in other embodiments.

FIG. 5 depicts details of a low-profile port 210 according to oneembodiment, including a body 212 defining a concavely-shaped receivingcup 214 and an inlet port 216 positioned slightly off-center withrespect to the receiving cup. A stem 224 is included as a fluid outlet.

FIG. 6 depicts the low-profile port 210 according to another embodiment,wherein the body 212 defining additional surface features, including araised palpation feature 226 distal to the receiving cup 214. In lightof FIGS. 5 and 6 , it is thus appreciated that the port can beconfigured in a variety of shapes and configurations to provide alow-profile solution for providing vascular access. Note also that thereceiving cup shape, design, and configuration can vary from isexplicitly shown and described herein.

FIGS. 7A and 7B depict various details of a low-profile dual-body accessport 310 according to one embodiment, wherein each of the port bodies312 defines a receiving cup 314 that is laterally facing and includes aninlet port 316 leading to a conduit 318. The conduit 318 extendsdistally to a valve/seal assembly 322 disposed in a valve housing 320,which in the present embodiment, is defined by a portion of the body312. The conduit 318 extends through the port 324. A compliantovermolded portion 324 covers portions of each body 312 of the port 310and operably joins the bodies to one another. The bodies 312 can includeany suitable material, including metal, thermoplastic, etc.

FIGS. 8A and 8B depict various details of a low-profile dual-body accessport 410 according to one embodiment, wherein a port body 412 definesdual fluid paths. Each fluid path includes a receiving cup 414 definedby the body 412 and facing a substantially upward orientation from theperspective shown in FIGS. 8A and 8B. An inlet port 416 is included witheach receiving cup 414 and defines the opening to a conduit 418. Eachconduit 418 extends distally to a valve/seal assembly 422 disposed in avalve housing 420, which in the present embodiment, is defined by aportion of the body 412. The conduit 418 extends through the port 424.The body 412 can include any suitable material, including metal,thermoplastic, etc.

Reference is now made to FIGS. 9A-30 , which depict various details ofembodiments generally directed to vascular access devices, also referredto herein as access ports, for subcutaneous implantation within the bodyof a patient. The implanted access ports to be described aretranscutaneously accessible by a catheter-bearing needle, such as aperipheral intravenous (“PIV”) catheter, so as to place the PIV catheterinto fluid communication with the access port. A fluid outlet of theaccess port is operably connected to an in-dwelling catheter disposedwithin the vasculature of a patient, in one embodiment, to enable theinfusion into and/or removal of fluids from the patient's vasculature totake place via the PIV catheter.

In accordance with one embodiment, the access port defines a relativelylow profile so as to facilitate ease of placement within thesubcutaneous tissue of the patient. Further, the access port isconfigured to provide a relatively large subcutaneous target to enablethe PIV catheter or other suitable catheter-bearing needle to access theport without difficulty. In addition, the access port includes avalve/seal assembly to permit power injection of fluids through theaccess port. As before, possible applications for the access portdescribed herein include administration of medicaments and other fluidsto the patient, pheresis/apheresis, fluid aspiration, etc.

Reference is first made to FIGS. 9A-9G, which show various details of avascular access device (also “access port” or “port”), generallydesignated at 510, in accordance with one embodiment. As shown, the port510 includes a body 512 that is defined in the present embodiment by afirst portion 512A and a second portion 512B (FIG. 9E). In the presentembodiment the port body 512 includes a metal such as titanium, and assuch, the second portion 512B is press fit into engagement with thefirst portion 512A to define the body, though it is appreciated that theport body can include a variety of other materials, including metals,thermoplastics, ceramics, etc.

The port body first portion 512A defines in the present embodiment asubstantially funnel-shaped receiving cup 514 for receiving anddirecting a catheter-bearing needle (FIG. 14A) to operably connect withthe port 510, as described further below. In particular, thesubstantially funnel shape of the receiving cup 514 is configured todirect the catheter-bearing needle (FIG. 14A) impinging thereon towardan inlet port 516 that serves as an opening for a conduit 518 defined bythe port body 512. The open and shallow nature of the receiving cup 514,angled toward the skin surface of the patient enables the receiving cupto present a large, easily accessible target for the needle whenintroduced into the skin, as seen in FIGS. 14A-14D. FIGS. 9B and 9Cfurther show that the port 510 defines a relatively low profile height,which enables relatively shorter needle lengths to be used for accessingthe port after implantation. Note that palpation features can beincluded with the port body 512 to assist a clinician to locate and/oridentify the port 510 via finger palpation after implantation under theskin of the patient, as with other embodiments herein. Further, inanother embodiment a guide groove can be defined on the receiving cup514 to be longitudinally aligned with the inlet port 516 of the conduit518, similar to that shown in the access port 10 of FIG. 1A.

Together with FIGS. 9A-9G, reference is also made to FIGS. 10 and 11 .As best seen in FIG. 11 , the port body 512 further defines the conduit518 as a pathway into which a transcutaneously inserted catheter canpass so as to place the catheter in fluid communication with the port510 and the indwelling catheter attached to the stem 524 thereof. Asshown, the conduit 518 is in fluid communication with the receiving cup514 via the inlet port 516. A first conduit portion 518A of the conduit518 distally extends from the inlet port 516 in an angled downwarddirection from the perspective shown in FIG. 11 to a bend 530, where asecond conduit portion 518B of the conduit extends substantiallyhorizontally (from the perspective shown in FIG. 11 ) at a predeterminedangle with respect to the first conduit portion. Note that predeterminedangle at the bend 530 in one embodiment is about 34 degrees, but canvary from this in other embodiments, including angles less or more than34 degrees in one embodiment. The magnitude of the predetermined angleat the bend 530 depends in one embodiment on various factors, includingthe size of the catheter and/or needle to be inserted into the portconduit, the size of the conduit itself, etc.

The conduit 518 then extends to and through a cavity 520A defined by avalve housing 520 of the port body 12 where a third conduit portion 518Cextends to a distal open end of the stem 524 of the port 510. In thepresent embodiment the conduit 518 is sized so as to enable the catheter40 (FIG. 14A) to pass therethrough to a predetermined point, as will beseen.

As mentioned, the valve housing 520, defined by portions of the firstand second portions 512A, 512B of the body 512 defines a cavity 520Athrough which the conduit 518 passes and which houses a valve/sealassembly 522. The valve/seal assembly 522 includes a sealing element, orseal 532, which defines a central hole 532A (FIGS. 12A-12C) throughwhich the catheter 40 (FIG. 14A) can pass, and a slit valve 534including two intersecting slits 534A (FIGS. 13A-13C). The seal 532 andvalve 534 are sandwiched together in one embodiment, with the seal 532disposed proximal to the valve 534, and secured in place within thecavity 520A as shown in FIG. 11 . The slits 534A of the slit valve 534are orthogonally offset from one another by about 90 degrees in thepresent embodiment, though other relationships are possible. Note thatthe valve 534 includes a central depression 535 to ease the transitionof passage of the catheter 40 from the seal 532 to the valve.

The seal 532 and valve 534 of the valve/seal assembly 522 cooperate toenable fluid-tight passage therethrough of the catheter 40 (FIG. 14A)while also preventing backflow of fluid through the valve/seal assembly.Indeed, in one embodiment the seals disclosed herein prevent fluid flowaround the external portion of the catheter when the catheter isdisposed through the seal 532, while the valve 534 is suitable forpreventing fluid flow when no catheter passes through them. As such,when the catheter 40 is not inserted therethrough the valve/sealassembly 522 seals to prevent passage of air or fluid through theconduit 518. In the present embodiment, the seal 532 and valve 534 arecomposed of silicone, such as SILASTIC® Q7-4850 liquid silicone rubberavailable from Dow Corning Corporation, though other suitably compliantmaterials can be employed. In one embodiment, silicone oil, such asNuSil Technology Med 400 silicone oil, is included with the seal 532 andvalve 534 to enhance lubricity and extend component life. In anotherembodiment, the silicone oil is infused into the silicone.

The port 510 in the present embodiment includes an overmolded portion536 that covers a majority portion of the port body 512. The overmoldedportion 536 includes silicone, such as SILASTIC® Q7-4850 liquid siliconerubber or other suitably compliant material and surrounds the body 512as shown so as to provide a relatively soft surface for the port 510 andreduce patient discomfort after port implantation within the patientbody. The overmolded portion 536 includes in one embodimentpredetermined suture locations 538, best seen in FIG. 9F, for suturingthe port 510 to patient tissue, though sutures may be passed throughother portions of the overmolded portion, if desired. The overmoldedportion 536 further defines a relatively flat bottom surface 536A so asto provide a stable surface for the port 510 in its position within thetissue pocket after implantation into the patient body.

FIGS. 9C and 9G show that the first body portion 512A defines asecurement ridge 537 that serves as an anchor to prevent relativemovement between the overmolded portion 536 and the body 512. Thesecurement ridge 537 can vary in shape, number, configuration, etc. Notethat the overmolded portion 536 in one embodiment is molded in a moldingprocess over the body 512. In another embodiment, the overmolded portion536 is separately formed then adhesively attached to the body 512, suchas via Med A adhesive. These and other configurations are thereforecontemplated.

FIGS. 14A-14D depict details regarding the insertion of the catheter 40disposed on the needle 42 into the port 510 (already subcutaneouslyimplanted into the body of the patient), according to one embodiment.After locating the port 510 (optionally via through-skin palpation ofpalpation features, such as a top portion of the overmolded portion 536and/or the receiving cup 514), a clinician uses the catheter-bearingneedle 42 to pierce a skin surface and insert the needle until a distaltip 42B thereof impinges on a portion of the receiving cup 514, as shownin FIG. 14A. Note that, because of the orientation of the receiving cup514 is angled substantially toward the skin surface, the needle 42 canimpinge on the receiving cup at an insertion angle that is relativelysteep, which facilitates ease of needle insertion into the body. Indeed,in one embodiment a needle inserted substantially orthogonally throughthe skin of the patient can impinge the receiving cup of the accessport. In another, embodiment, the insertion angle of the needle 42 canbe relatively shallow, similar to current insertion angles for IVcatheters.

The needle 42 is manipulated by the clinician and guided by impingementon the receiving cup 514 until the needle distal tip 42B is guided tothe inlet port 516. The needle 42 is then inserted through the inletport 516 and into the first portion 518A of the conduit 518 until it isstopped by the bend 530, as seen in FIG. 14B. The needle 42 can then beproximally backed out a small distance, and the catheter 40 advancedover the needle such that the catheter bends and advances past the bend530 into the second portion 518B of the conduit 518, as seen in FIG.14C. Catheter advancement continues such that a distal end 40B of thecatheter 40 advances into and past the hole 532A of the seal 532 andthrough both slits 534A of the slit valve 534 of the valve/seal assembly522. Note that the length of the second conduit portion 518B issufficient to enable the cross-sectional shape of the distal portion ofthe catheter 40 to return to a substantially round shape from the ovalshape imposed thereon as a result of its passage through the conduitbend 530.

Once the distal end 40B of the catheter 40 has extended distally pastthe valve/seal assembly 522, further advancement is prevented byimpingement of the catheter distal end against an annular stop surface539 included in the third conduit portion 518C defined by the stem 524,as shown in FIG. 14D and in more detail in FIG. 11 . In one embodiment,the stop surface 539 is defined as an annular shoulder and is sized soas to stop advancement of one size of catheter, such as 14 Gaugecatheter, while allowing a 16 Gauge catheter to pass. In anotherembodiment, no stop surface is included in the conduit 518, thusenabling the catheter 40 to advance completely past the distal end ofthe stem 524, if desired. Note that the port conduit can be configuredto accept one or more of a variety of catheter Gauge sizes, including 14Gauge, 16 Gauge, 18 Gauge, etc.

Once the catheter 40 is positioned as shown in FIG. 14D, the needle 42can be fully removed and fluid transfer through the catheter 40 and port510 can commence, including infusion and/or aspiration through anindwelling catheter attached to the stem 524. (Note that the needle 42can be removed at another stage of the catheter insertion procedure, inone embodiment.) Dressing of the catheter 40 can also occur as needed.Once fluid transfer is completed, the catheter 40 can be withdrawnproximally through the valve/seal assembly 522 and the conduit 518, thenwithdrawn through the surface of the skin and out of the patient.

FIG. 9F depicts that, in the present embodiment, the receiving cup 514includes radiopaque indicia 528 to indicate a characteristic of the port510. Here, the radiopaque indicia 528 includes an “IVCT” alphanumericdesignation that is defined as a depression or recess into the titaniummaterial forming the first body portion 512A so as to be visible afterport implantation via x-ray imaging technology. The “IVCT” designationindicates that the port 510 is configured for power injection and isfurther configured to receive therein a peripheral IV catheter.

In another embodiment the radiopaque indicia 528 can be included byemploying radiopaque material that can be formed as an insert that isinsert-molded included in the port body, such as an initially flowablematerial that is injected into a cavity of the port body beforehardening, etc. In embodiments where the port body is metallic, theradiopaque indicia can be formed by metal injection molding, machining,etching, engraving, or otherwise producing a relative thicknessdifference between the indicia and the surrounding port body material soas to produce an x-ray-discernible contrast that shows up in an x-rayimage, similar to FIG. 1F.

In addition to above designation, other characteristics can be indicatedby various other types of radiopaque indicia as appreciated by oneskilled in the art.

As in other embodiments described herein, in one embodiment theperimeter of the receiving cup (or other suitable location) can includepalpation features, such as three raised bumps in the overmolded portion536 to assist in locating the position of the receiving cup 514post-implantation when they are palpated by a clinician prior to needleinsertion into the patient. Various other palpation features could beincluded with the port, in other embodiments, including disposal on thereceiving cup itself, etc.

FIGS. 15A and 15B depict details of a guide device 550 that can beplaced on the patient skin atop the implanted location of the port 510shown in FIGS. 9A-9G to assist in guiding the needle 42 through the skinso as to impinge on the receiving cup 514, as desired. As shown, theguide device 550 includes a body 552 that defines a cavity 554 intowhich a portion of the subcutaneous implanted port 510 will reside whenthe guide device is pressed on the skin over the port. A notch 556 isincluded on the body 552, partially bordered by a ridge 558. The notch556 enables the needle 42 to be passed therethrough so as to be insertedthrough the skin and into port 510. A marker line 560 is included on theridge 548 to assist the clinician in placing the needle 42 at the properorientation and location for impingement on the receiving cup 514, asdesired. Note that the shape, size, and other configuration of the guidedevice can vary from what is shown and described herein.

Reference is now made to FIGS. 25A-25E, which show various details of adual-lumen vascular access device, generally designated at 810, inaccordance with one embodiment. As shown, the port 810 includes a body812 that is defined in the present embodiment by two similarly shapedportions: a single first portion 812A and a single second portion 812B(FIG. 25C). In the present embodiment the port body first and secondportions 812A, 812B include a metal such as titanium, and as such, thesecond portion is press fit into engagement with the first portion todefine the body, though it is appreciated that the port body can includea variety of other materials, including metals, thermoplastics,ceramics, etc., and can include other joining methods includingadhesive, ultrasonic or other welding, interference fit, etc.

Both port body first portions 812A define in the present embodiment asubstantially funnel-shaped receiving cup 814 for receiving anddirecting the catheter-bearing needle 42 (FIG. 14A) to operably connectwith the port 810 in a manner similar to that already described above.In particular, the substantially funnel shape of each receiving cup 814is configured to direct the catheter-bearing needle 42 impinging thereontoward an inlet port 816 that serves as an opening for a respectiveconduit 818 defined by the port body 812. The open and shallow nature ofeach receiving cup 814, angled toward the skin surface of the patientenables the receiving cup to present a large, easily accessible targetfor the needle when introduced into the skin and directed toward thesubcutaneously implanted access port 810. FIG. 25B further shows thatthe access port 810 defines a relatively low profile height, whichenables relatively shorter needle lengths to be used for accessing thesubcutaneous access port after implantation.

Note that, as already mentioned, palpation features can be included withthe port body 812 in one embodiment to assist a clinician to locateand/or identify the port 810 via finger palpation after implantationunder the skin of the patient. Note that a variety of sizes,configurations, numbers, etc., of palpation features can be included onthe port. In another embodiment, a guide groove can be defined on thereceiving cup 814 to be longitudinally aligned with the inlet port 816of the conduit 818, as discussed in connection with the embodiment ofFIGS. 1A-2 . The guide groove can be defined as a depression withrespect to adjacent portions of the surface of the receiving cup 814 andextend distally along the receiving cup surface from a proximal portionof the receiving cup so as to provide a guide path to guide the distaltip of the catheter-bearing needle toward the inlet port 816 onceimpingement of the needle into the guide groove is made. This in turnreduces the chance the needle will slide across and off the receivingcup 814 during insertion. Note that these and other similar features,though differing in shape and configuration, can also be included on theother ports disclosed herein.

In an embodiment, the receiving cup 814 is covered by a septum 840. Theseptum 840 can be a self-sealing, needle penetrable septum, capable ofreceiving multiple needle piercings to allow access to the receiving cup814 there below. Accordingly, the septum 840 can be made of a suitableneedle-penetrable material, such as silicone, or the like. The septum840 includes an outer surface 842 and an inner surface 844 opposite thatof the outer surface 842 and substantially facing receiving cup 814.Either of the outer or inner surfaces 842, 844 can be flat or slightlyconvex. In an embodiment, the inner surface 844 is substantially flatwhile the outer surface 842 is convex to align with the rounded outersurface of the overmolded portion 836 and provide a continuous outerprofile to the port 810. Advantageously, the septum 840 completes aconvexly rounded outer profile to the port 810 that allows for a smoothimplantation of the device within a tissue pocket and reduces patientdiscomfort after port implantation within the patient body. Further theseptum 840 can prevent tissue ingrowth into the receiving cup 814, andassociated conduits 818, that would otherwise obstruct the path of theneedle entering the device. Accordingly, the septum 840 preventsadditional surgeries required to remove such obstructions or to replacethe device 810 prematurely. It will be appreciated that septum 840 canalso be applied to any embodiment disclosed herein.

As best seen in FIG. 25D, the port body 812 further defines the twoconduits 818, each conduit serving as a pathway into which atranscutaneously inserted catheter can be partially inserted so as toplace the catheter in fluid communication both with the port 810 and anindwelling dual-lumen catheter operably attached to two fluid outlets824A of a stem 824 of the port. As shown, the conduit 818 of each portbody first portion 812A is in fluid communication with its respectivereceiving cup 814 via the inlet port 816. A first conduit portion 818Aof the conduit 818 distally extends from the inlet port 816 in an angleddownward direction from the perspective shown in FIG. 25D to a conduitbend 830, where a second conduit portion 818B of the conduit extends ata predetermined angle with respect to the first conduit portion. Notethat predetermined angle at the bend 830 in one embodiment is about 34degrees, but can vary from this in other embodiments, including anglessmaller or greater than 34 degrees in one embodiment. The magnitude ofthe predetermined angle at the bend 830 depends in one embodiment onvarious factors, including the size of the catheter and/or needle to beinserted into the port conduit, the size of the conduit itself, etc.Note also that the conduit bend 830 serves as a needle-stop feature,preventing the needle 42 from advancing along the conduit 818 past thebend 830.

The second conduit portion 818B of each port body first portion 812Adistally extends to a cavity 820A defined by the press-fit junction ofthe port body first portion and the second portion 812B, as seen in FIG.25D. Two third conduit portions 818C are defined by the second portion812B of the port body 812 and extend from each of the cavities 820A in apartially arcuate fluid path to the distally-disposed fluid outlets 824Aof the stem 824. In the present embodiment the conduit 818 is sized soas to enable the catheter 40 (FIG. 14A) to pass therethrough and pastthe cavity 820A.

As mentioned, the cavities 820A, each defined by the junction of therespective first portion 812A and the second portion 812B of the portbody 812, each define a space through which the conduit 818 passes andin which is housed a valve/seal assembly 822. In the present embodimentand as best seen in FIGS. 25C and 25D, the valve/seal assembly 822includes a sealing element, or seal 832, which defines a central hole832A through which the catheter 40 (FIGS. 14A, 14D) can pass, and a slitvalve 834 including two orthogonally intersecting slits 834A throughwhich the catheter also passes. The seal 832 and slit valve 834 aresandwiched together in one embodiment, with the seal disposed proximalto the slit valve, and secured in place within the correspondingly sizedcavity 820A as shown in FIG. 25D.

As mentioned, the slits 834A of the slit valve 834 are orthogonallyoffset from one another by about 90 degrees in the present embodiment,though other relationships are possible, including the use of twosingle-slit valves sandwiched together with one another. Note that inthe present embodiment the slit valve 834 includes a central depression(as in previous embodiments, such as is shown in FIG. 13A, for instance)to ease the transition of passage of the catheter 40 from the seal 832to the valve. More than one seal and/or slit valve may be employed inthe valve/seal assembly in other embodiments.

As with previous embodiments, the seal 832 and slit valve 834 of thevalve/seal assembly 822 cooperate to enable fluid-tight passagetherethrough of the catheter 40 (see, e.g., FIG. 14A) while alsopreventing backflow of fluid through the valve/seal assembly. Indeed, inone embodiment the seals disclosed herein prevent fluid flow around theexternal portion of the catheter when the catheter is disposed throughthe seal 832, while the valve 834 is suitable for preventing fluid flowwhen no catheter passes through them. As such, when the catheter 40 isnot inserted therethrough the valve/seal assembly 822 seals to preventpassage of air or fluid through the conduit 818. In the presentembodiment, the seal 832 and valve 834 are composed of silicone, such asSILASTIC® Q7-4850 liquid silicone rubber available from Dow CorningCorporation, though other suitably compliant materials can be employed.In one embodiment, silicone oil, such as NuSil Technology Med 400silicone oil, is included with the seal 832 and valve 834 to enhancelubricity and extend component life. In another embodiment, the siliconeoil is infused into the silicone.

The port 810 in the present embodiment includes an overmolded portion836 that covers a portion of the port body 812, including a majorityportion of each of the two first portions 818A. The overmolded portion836 includes silicone, such as SILASTIC® Q7-4850 liquid silicone rubberor other suitably compliant material and surrounds the portions of thebody 812 as shown in FIGS. 25A and 25B so as to provide a relativelysoft surface for the port 810 and reduce patient discomfort after portimplantation within the patient body. The overmolded portion 836 furtherenables a clinician to suture through one or more of various portions ofthe overmolded portion to enable the port 810 to be secured within asubcutaneous patient tissue pocket. The overmolded portion 836 furtherdefines a relatively flat bottom surface 836A so as to provide a stablesurface for the port 810 in its position within the tissue pocket afterimplantation into the patient body.

FIG. 25B shows that the first body portions 812A each define asecurement ridge 837 that serves as an anchor to prevent relativemovement between the overmolded portion 836 and the body 812. Thesecurement ridge 837 can vary in shape, number, configuration, etc. Notethat the overmolded portion 836 in one embodiment is molded in a moldingprocess over the body 812. In another embodiment, the overmolded portion836 is separately formed then adhesively attached to the body 812, suchas via Med A adhesive. These and other configurations are thereforecontemplated.

FIG. 25E shows that underside surfaces of the receiving cups 814 includea radiopaque indicia 828 configured to enable the port 810 to beradiographically identified after implantation into the patient body. Inthe present embodiment each of the indicia 828 includes the letters “IV”and “CT” to indicate suitability of the port 810 to receive peripheralIV catheters and that the port is capable of power injection of fluidstherethrough. Of course, a variety of other indicia, including letters,numbers, symbols, etc., may be used.

FIGS. 26A-26D depict various details of the port 810 according toanother embodiment, wherein the port body 812 defines a relativelyslimmer profile than the embodiment shown in FIGS. 25A-25E, madepossible by defining a cutout 870 on both receiving cups 814 of eachfirst portion 812A of the port body 812. This enables the receiving cups814 to reside relatively close to one another. The receiving cups 814can be joined to one another along the cutouts 870 via welding,adhesive, forming the receiving cups together as a single component,etc.

In one embodiment, it is appreciated that the receiving cups 814 can beoriented in other configurations. FIG. 31 gives an example of this,wherein a partially exploded view of the port 810 is shown without theovermolded portion 836 present, and thus including the two firstportions 812A and the second portion 812B. As shown, the receiving cups814 are angled with respect to one another such that a perimeter 814A ofa corresponding one of the receiving cups lies in an imaginary plane890A that is non-parallel to another plane 890B in which a perimeter814B of the other receiving cup lies. This is in contrast to anotherembodiment, such as that shown in FIG. 25A, wherein the receiving cups814 substantially lie in a single imaginary plane. The configuration ofFIG. 31 results in the receiving cups 814 being angled away from oneanother, as shown in FIG. 31 (note that the first body portion 812Ashown disconnected (for clarity) from the second body portion 812B is tobe connected to the second body portion in substantially the sameorientation as shown in FIG. 31 ). This, in turn, desirably results in aslightly lower height profile for the access port 810, and can alsoresult in the needle 42 inserted therein residing relatively closer tothe patient skin, in one embodiment. Note that the receiving cups can beangled in various different configurations in addition to what is shownand described herein.

Reference is now made to FIGS. 16A-21B, which depict details of adual-lumen vascular access device, generally designated at 610, inaccordance with one embodiment. As shown, the port 610 includes a body612 that is defined in the present embodiment by a first portion 612Aand a relatively smaller second portion 612B that is partially receivedwithin the first portion. In the present embodiment the port body firstand second portions 612A, 612B include a metal such as titanium, and assuch, the second portion is press fit into engagement with the firstportion to define the body, though it is appreciated that the port bodycan include a variety of other materials, including metals,thermoplastics, ceramics, etc., and can include other joining methodsincluding adhesive, ultrasonic or other welding, interference fit, etc.

The port body first portion 612A defines in the present embodiment twosubstantially funnel-shaped receiving cups 614 for receiving anddirecting the catheter-bearing needle 42 (FIG. 14A) to operably connectwith the port 610 in a manner similar to that already described above.The receiving cups 614 in the present embodiment are disposed so as tobe substantially aligned along a longitudinal axis of the port 610,though other positional arrangements for the receiving cups arepossible, including side-by-side, spaced-apart, staggered, etc.

In particular, the substantially funneled-shape of each receiving cup614 is configured to direct the catheter-bearing needle 42 impingingthereon toward an inlet port 616 that serves as an opening for arespective one of two conduits 618 defined by the port body 612, oneconduit for each receiving cup. The open and shallow nature of eachreceiving cup 614, angled toward the skin surface of the patient enablesthe receiving cup to present a large, easily accessible target for theneedle when introduced into the skin and directed toward thesubcutaneously implanted access port 610. FIGS. 16C and 16F further showthat the access port 610 defines a relatively low profile height, whichenables relatively shorter needle lengths to be used for accessing thesubcutaneous access port after implantation.

The port body 612 further defines a palpation feature 637, hereconfigured as a raised surface interposed between the longitudinallyaligned receiving cups 614. As mentioned above, the palpation feature637 is included with the port body 612 to assist a clinician to locateand/or identify the port 610 via finger palpation after implantationunder the skin of the patient. Note that a variety of sizes,configurations, numbers, etc., of palpation features can be included onthe port. In another embodiment, a guide groove can be defined on eachreceiving cup 614 to be longitudinally aligned with the inlet port 616of the conduit 618, as in previous embodiments.

As best seen in FIGS. 17A, 17B, and 19 , the port body 612 furtherdefines the above-mentioned two conduits 618, each conduit serving as apathway into which a transcutaneously inserted catheter can be partiallyinserted so as to place the catheter in fluid communication both withthe port 610 and an indwelling dual-lumen catheter operably attached totwo fluid outlets 624A of a stem 624 of the port. As shown, the twoconduits 618 of the port body first portion 612A are in fluidcommunication with their respective receiving cup 614 via thecorresponding inlet port 616. A first conduit portion 618A of eachconduit 618 distally extends from the respective inlet port 616 in anangled downward direction from the perspective shown in FIG. 17A to aconduit bend 630 (FIG. 19 ), where the first conduit portion extendsdistally at a predetermined angle with respect to the first conduitportion proximal to the conduit bend. The magnitude of the predeterminedangle at the bend 630 depends in one embodiment on various factors,including the size of the catheter and/or needle to be inserted into theport conduit, the size of the port and the conduit itself, etc. Notealso that the conduit bend 630 serves as a needle-stop feature,preventing the needle 42 from advancing along the conduit 618 past thebend 630.

The first portion 618A of the relatively more distal of the tworeceiving cups 614 extends to a cavity 620A defined by and proximate tothe distal portion of the first portion 612A of the port body 612, asbest seen in FIGS. 18 and 19 . The first portion 618A of the relativelymore proximal of the two receiving cups 614 also extends to a cavity620A that is defined by, but relatively more proximally distant from,the distal portion of the first portion 612A of the port body 612 (FIGS.18 and 19 ). A second conduit portion 618B is defined for this latterconduit 618 by the second portion 612A of the port body 612, as seen inFIGS. 17A and 17B and extends distally from its respective cavity 620Auntil joining with a third conduit portion 618C defined by the secondportion 612A of the port body, which extends through the second portionand the stem 624 until terminating at a respective one of the fluidoutlets 624A (FIG. 20 ).

The conduit 618 for the relatively more distal receiving cup 614 extendsfrom the cavity 620A to a third conduit portion 618C defined by thesecond portion 612A of the port body 612, as seen in FIG. 20 , whichextends through the second portion and the stem 624 until terminating ata respective one of the fluid outlets 624A. In this way, fluid pathwaysare defined for each receiving cup 614 from the inlet port 616 to thestem fluid outlet 624A, as depicted in FIGS. 21A and 21B. In the presentembodiment the conduit 618 is sized so as to enable the catheter 40(FIG. 14A) to pass therethrough past the cavity 620A.

As mentioned, the cavities 620A, each disposed in the fluid pathwaydefined by the various portions of the conduits 618, each define a spacethrough which the conduit 618 passes and in which is housed a valve/sealassembly 622. In the present embodiment and as best seen in FIGS. 17A-18, each valve/seal assembly 622 includes a sealing element, or seal 632,which defines a central hole 632A (FIG. 21B) through which the catheter40 (FIGS. 14A, 14D) can pass, and two adjacently placed slit valves 634,each slit valve including a single slit 634A (with the valves beingarranged such that the slits are orthogonal to one another), throughwhich the catheter also passes. The seal 632 and slit valves 634 aresandwiched together in one embodiment, with the seal disposed proximalto the slit valve, and secured in place within the correspondingly sizedcavity 620A as shown in FIGS. 17A and 17B. In another embodiment, thevalve/seal assembly includes a single seal and a single, dual-slitvalve, as in previous embodiments.

In the present embodiment, the seal 632 and valves 634 are composed ofsilicone, such as SILASTIC® Q7-4850 liquid silicone rubber availablefrom Dow Corning Corporation, though other suitably compliant materialscan be employed. In one embodiment, silicone oil, such as NuSilTechnology Med 400 silicone oil, is included with the seal 632 andvalves 634 to enhance lubricity and extend component life. In anotherembodiment, the silicone oil is infused into the silicone. Also, and ashas been mentioned with other embodiments, other seal/valveconfigurations can also be employed in the port 610.

Reference is now made to FIGS. 22A-24 , which show various details of adual-lumen vascular access device, generally designated at 710, inaccordance with one embodiment. As shown, the port 710 includes a body712 that is defined in the present embodiment by a first portion 712Adefining the majority of the external portion of the port body and asecond portion 712B that is matable to the first portion. In the presentembodiment the port body first and second portions 712A, 712B include ametal such as titanium, and as such, the second portion is press fitinto engagement with the first portion to define the body 212, though itis appreciated that the port body can include a variety of othermaterials, including metals, thermoplastics, ceramics, etc., and caninclude other joining methods including adhesive, ultrasonic or otherwelding, interference fit, etc.

The port body first portion 712A defines in the present embodiment twosubstantially concavely-shaped receiving cups 714, side-by-side in aspaced-apart arrangement, for receiving and directing thecatheter-bearing needle 42 (FIG. 14A) to operably connect with the port710 in a manner similar to that already described above. In particular,the substantially concave shape of each receiving cup 714 is configuredto direct the catheter-bearing needle 42 impinging thereon toward aninlet port 716 that serves as an opening for a respective conduit 718defined by the port body 712.

The open and shallow nature of each receiving cup 714, angled toward theskin surface of the patient enables the receiving cup to present alarge, easily accessible target for the needle when introduced into theskin and directed toward the subcutaneously implanted access port 710.FIGS. 22A and 22B further show that the access port 710 defines arelatively low profile height, which enables relatively shorter needlelengths to be used for accessing the subcutaneous access port afterimplantation. FIG. 22C depicts details of a bottom portion of the portbody 712. Note that in this and other embodiments, the receiving cupscan define different surfaces, including funnel-shaped, concave-shaped,hemispherical, etc.

The port body 712 includes a plurality of palpation features 737, hereimplemented as ridges extending distally from the receiving cups 714, toassist a clinician to locate and/or identify the port 710 via fingerpalpation after implantation under the skin of the patient. Note that avariety of sizes, configurations, numbers, etc., of palpation featurescan be included on the port.

As best seen in FIGS. 23 and 24 , the port body 712 further defines thetwo conduits 718, each conduit serving as a pathway into which atranscutaneously inserted catheter can be partially inserted so as toplace the catheter in fluid communication both with the port 710 and anindwelling dual-lumen catheter operably attached to two fluid outlets724A of a stem 724 of the port. As shown, each of the two conduits 718of the port body first portion 712A is in fluid communication with itsrespective receiving cup 714 via the inlet port 716 and extends distallyto a valve/seal assembly 722 disposed in a cavity cooperatively definedby the junction of the port body first portion 712A and the secondportion 712B. As with other embodiments herein, each conduit 718distally extends from the respective inlet port 716 in an angleddownward direction from the perspective shown in FIG. 23 to a conduitbend before continuing to the cavity wherein is disposed the valve/sealassembly. Note that the conduit bend can desirably serve as aneedle-stop feature, preventing the needle 42 from advancing along theconduit 718 past the bend. The conduits distally extend past thevalve/seal assembly 722 and through the port body second portion 712B tothe fluid outlets of the stem 724. In the present embodiment the conduit718 is sized so as to enable the catheter 40 (FIG. 14A) to passtherethrough past the valve/seal assembly 722.

As mentioned, the cavities, each defined by the junction of therespective first portion 712A and the second portion 712B of the portbody 712, each define a space through which the conduit 718 passes andin which is housed the valve/seal assembly 722. In the presentembodiment and as best seen in FIGS. 23 and 24 , each of the twovalve/seal assemblies 722 includes a sealing element, or seal 732, whichdefines a central hole through which the catheter 40 (FIGS. 14A, 14D)can pass, and two slit valves 734, each including a single slit andpositioned adjacent each other such that the slits are substantiallyorthogonal to one another, through which the catheter also passes. Theseal 732 and the slit valves 734 are sandwiched together in oneembodiment, with the seal disposed proximal to the slit valves, andsecured in place within the correspondingly sized cavity as shown inFIGS. 23 and 24 .

As mentioned, the slits of the slit valves 734 are orthogonally offsetfrom one another by about 90 degrees in the present embodiment, thoughother relationships are possible, including the use of a single slitvalve including two orthogonal slits. These and other modifications tothis and the other valve/seal assembly embodiments herein are thereforecontemplated.

As with previous embodiments, the seal 732 and slit valves 734 of thevalve/seal assembly 722 cooperate to enable fluid-tight passagetherethrough of the catheter 40 (see, e.g., FIG. 14A) while alsopreventing backflow of fluid through the valve/seal assembly. Indeed, inone embodiment the seals disclosed herein prevent fluid flow around theexternal portion of the catheter when the catheter is disposed throughthe seal 732, while the valve 734 is suitable for preventing fluid flowwhen no catheter passes through them. As such, when the catheter 40 isnot inserted therethrough the valve/seal assembly 722 seals to preventpassage of air or fluid through the conduit 718. In the presentembodiment, the seal 732 and valve 734 are composed of silicone, such asSILASTI^(C)® Q7-4850 liquid silicone rubber available from Dow CorningCorporation, though other suitably compliant materials can be employed.In one embodiment, silicone oil, such as NuSil Technology Med 400silicone oil, is included with the seal 732 and valve 734 to enhancelubricity and extend component life. In another embodiment, the siliconeoil is infused into the silicone.

Though not explicitly shown here, the port 710, as with otherembodiments herein, can include radiopaque indicia configured to enablethe port to be radiographically identified after implantation into thepatient body. In one embodiment, the indicia include the letters “IV”and “CT” to indicate suitability of the port 710 to receive peripheralIV catheters and that the port is capable of power injection of fluidstherethrough. Of course, a variety of other indicia, including letters,numbers, symbols, etc., may be used.

Though single and dual-port configurations have been described herein,it is appreciated that ports including more than two receiving cups arecontemplated. Note also that certain of the receiving cups describedherein are described as funnel shaped, while other receiving cups aredescribed herein as concavely shaped. It is noted that that thereceiving cups can interchangeably include aspects of one or the other,or both, of these receiving cup shapes, according to a particularembodiment.

FIGS. 27-30 depict details of various possible configurations for thevalve/seal assembly, according to example embodiments. In FIG. 27 , theseal 32 includes a central depression 380, similar but relativelysteeper than the depression 35 of the valve 34. In FIG. 28 , two sealsare included—the seal 32 and a second seal 382 interposed between theseal 32 and the valve 34. The second seal 382 includes a central hole382A that includes a diameter smaller relative to the hole 32A of theseal 32. FIG. 29 includes a similar configuration, but the hole 382A issimilar in size to the hole 32A. A small central depression 35 isincluded on the valve 34 in both FIG. 28 and FIG. 29 .

In FIG. 30 , the seal 32 includes a relatively small-diameter centralhole 32A, and the valve 34 includes a relatively large centraldepression 35. Note that the valve/seal assemblies shown in FIGS. 27-30are oriented in the figures such that the catheter pierces the seals andvalves in a direction corresponding from the top of the page toward thebottom of the page.

Reference is now made to FIGS. 32A-32B, which show various details of amulti-lumen vascular access device, generally designated at 910 inaccordance with one embodiment. As shown, the port 910 includes a body912 that is defined in the present embodiment by a first portion 912Aand a relatively smaller second portion 912B that is partially receivedwithin the first portion 912A. In the present embodiment, the port bodyfirst and second portions 912A, 912B include a metal such as titanium,and as such, the second portion is press fit into engagement with thefirst portion to define the body 912. However, it will be appreciatedthat the port body can include a variety of other suitable materials,including metals, thermoplastics, ceramics, etc., and can include otherjoining methods including snap-fitted, adhesive, ultrasonic or otherwelding, interference fit, etc., as discussed herein.

The port body first portion 912A defines in the present embodiment aplurality of substantially funnel-shaped receiving cups 914 forreceiving and directing the catheter-bearing needle 42 (FIG. 14A) tooperably connect with the port 910 in a manner similar to that alreadydescribed above. The receiving cups 914 in the present embodiment aredisposed in sets, or groups, so as a first set of receiving cups 914Aand second set of receiving cups 914B are substantially aligned along alongitudinal axis of the port 910, such that a first set 914A isproximal to second set of receiving cups 914B, though other positionalarrangements for the receiving cups are possible, includingside-by-side, spaced-apart, staggered, etc. As shown in FIG. 32B, eachset of receiving cups 914A, 914B include three individual receiving cups914, although it will be appreciated that a greater or fewer number ofreceiving cups 914 within each set 914A, 914B are contemplated and fallwithin the scope of the present invention.

In an embodiment, port body 912 includes sets of receiving cups 914A,914B that include individually defined receiving cups 914 similar tothose shown in FIG. 25A. In an embodiment, as shown in FIG. 32A, each ofthe receiving cups 914 within a set 914A, 914B can be joined to oneanother along cutouts 970. This enables the receiving cups 914 to residerelatively close to one another and provide port body 912 with arelatively slimmer profile than that of an embodiment where receivingcups 914 are individually defined. The receiving cups 914 of each set914A, 914B can be joined to one another along the cutouts 970 viawelding, adhesive, forming the welding cups together as a singlecomponent. In an embodiment each set of receiving cups 914A, 914B areformed as a single monolithic piece. In an embodiment, port body secondportion 912B is formed as a single monolithic piece.

The substantially funneled-shape of each receiving cup 914 is configuredto direct the catheter-bearing needle 42 impinging thereon toward acorresponding inlet port 916 for each cup 914. Each set of receivingcups 914A, 914B then communicates with a single conduit 918, i.e.conduit 918A, 918B respectively. The conduits 918A, 918B, in turncommunicate with a corresponding stem fluid outlet 924A, 924B of portstem 924, as described herein. Further, each of the conduits 918 caninclude valve/seal assemblies 922, also as described herein.Accordingly, a given conduit, e.g. 918A or 918B, can accessed by any ofthe receiving cups within a corresponding set of receiving cups 914A,914B. One embodiment of suitable internal inlet port 916/conduit 918routing is disclosed in FIG. 32B.

Advantageously, this allows a user to access a conduit 918 via multipleneedle entry points. Accordingly, the port 910 is suitable forimplantation under the skin of a dialysis patient, or patient undergoingsimilar extracorporeal treatments that require infusion and removal offluids from the vasculature. Multiple needle entry points can be usedand can be alternately selected over the course of multiple dialysistreatments so that no single locus of the patient's skin needs to beconsecutively penetrated by a needle in order to access a given conduit918.

In an embodiment, each the receiving cups 914 within a set can beoriented along a similar plane, such that they are co-aligned. In anembodiment, each of the receiving cups 914 within a set are angled withrespect to one another such that a perimeter 990 of a first receivingcup 914 lies in an imaginary plane 990A that is non-parallel the planesdefined by the perimeters of the other receiving cups 914 within theset, for example plane 990B defined by a second receiving cup 914, asdescribed herein (FIG. 31 ). Such a configuration results in each of thereceiving cups 914 within a set 914A, 914B being angled away from oneanother. This, in turn, desirably results in a slightly lower heightprofile for the access port 910, and can also result in the needle 42inserted therein residing relatively closer to the patient skin.Further, the angled receiving cups 914 provide a greater skin surfacewith which to access the port 910. Accordingly, repeated access can beachieved using a greater number of needle access points so that nosingle locus of the patient's skin needs to be consecutively penetratedby a needle, allowing previous sites to heal. Note that the receivingcups can be angled in various different configurations in addition towhat is shown and described herein.

Although two sets of three receiving cups each are shown, it will beappreciated that any number of receiving cups, or number of setsthereof, fall within the scope of the present invention. Accordingly, inan embodiment, one set of receiving cups may be configured for bloodwithdrawal, and the other set configured for blood return.

Reference is now made to FIG. 33 which illustrates an embodiment of asubcutaneous catheter assembly. The catheter assembly comprises acatheter 50, a bifurcation hub 60, an extension leg 70, such asextension legs 70A, 70B, and a port 10. The catheter 50 can be amulti-lumen catheter, such as a dual lumen dialysis catheter where eachlumen is fluidly connected with an extension leg 70A, 70B. A port 10 isfluidly connected with a proximal end of the extension leg 70 and can beconfigured for receiving dialysis needles or large gauge over-the-needleintravenous catheters. Accordingly, a first port 10A can be accessed tofluid removal and a second port 10B can be access for fluid return. Eachport 10 can include palpation features, indicia, guide grooves,radiopaque markers, or other features of other embodiments as disclosedherein.

Advantageously, the length and flexibility of the extension legs 70allow an amount of variation in positioning of the ports 10A, 10Brelative to each other. Accordingly, the ports can be positioned toalter the access locus on the patient's skin without having toreposition the entire device. Further, individual ports 10 can bereplaced as needed without having to replace the entire device. It willbe appreciated that alternate embodiments of port as disclosed hereincan be used in place of port 10. Further, catheters with differentnumbers of lumens and gauge sizes can also be used and fall within thescope of the present invention.

Reference is now made to FIGS. 34A-34B, which show various details of amulti-lumen vascular access device, generally designated at 1010 inaccordance with one embodiment. The port 1010 is configured to besurgically implanted under the skin of a patient, and includes a portbody 1012 fluidly connected with an in-dwelling, multi-lumen catheter1002 disposed within the vasculature of a patient. The port body 1012comprises two elongate, compliant arms, 1014A, 1014B, each of whichdefine a lumen 1020A, 1020B therein, which are fluidly connected with alumen of the in-dwelling, multi-lumen catheter 1002, by way of abifurcation hub 1016. The arms 1014, including the lumens 1020 disposedtherein, extend proximally from a proximal end of the bifurcation hub1016 along a longitudinal axis. Although FIGS. 34A-34B show two armsextending side by side along a longitudinal axis, other numbers of arms1014 and configurations thereof are contemplated. For example, at leastone arm 1014 can extend at an angle relative to the longitudinal axis. Aproximal end of each of the arms 1014A, 1014B, terminates in an end cap1018A, 1018B. The end cap 1018 can be formed of the same or of adifferent material from that of the arms and can be attached theretousing adhesive, welding, bonding, or similar suitable techniques. In anembodiment, the caps are formed monolithically with the arms 1014. Theport 1010, or portions thereof, can be formed of any suitablebiocompatible material, as discussed herein.

The port 1010, or portions thereof, can include palpation features 1026.For example, bifurcation hub 1016, end caps 1018, or combinationsthereof can include palpation features that can indicate a positionand/or orientation of the port body 1012, arms 1014, or the like, asdiscussed herein. Further, port 1010, portions thereof, or indiciaincluded therewith, can include metals, such as titanium, that areradiopaque thus allowing the port 1010 to be located and identifiedusing a suitable imaging modality, as discussed herein. For example, endcap 1018, arm 1014, bifurcation hub 1016, or combinations thereof, caninclude a radiopaque material to indicate a position and/or orientationof the port 1010, subsequent to subcutaneous implantation, using asuitable imaging modality, e.g., x-ray, CAT, PET, MRI, ultrasound, orthe like. To note, the bifurcation hub 1016 and the end cap 1018 caninclude differently shaped palpation features 1026/radiopaque indicia toindicate to a user a flow direction. A needle 42 can then be inserted atan obtuse angle relative to the flow direction. It will be appreciatedthat the needle 42 can also be inserted substantially orthogonal to thelongitudinal axis of the port 1010.

A portion of the arms 1014 can include a self-sealing, needle penetrablematerial, such as silicone, or the like. The self-sealing, needlepenetrable material can be disposed in an upper wall 1022 of the arms1014. Further, a lower wall 1024 of the arms can include aneedle-impenetrable material, for example, plastic, metal, or the like.The upper and lower walls 1022, 1024 can be defined relative to thetransverse axis. As noted the arms 1014 are compliant, this enables thearms to conform to the specific contours of the patient's body where itis subcutaneously implanted. Accordingly, while the material of thelower wall 1024 is needle impenetrable, the material is alsosufficiently compliant to conform to the patient's body. In anembodiment, a portion of the inner surface of the lumen 1020 includes aneedle impenetrable material, such as those discussed herein, thatprevents the distal end of a needle from gouging the inner surface ofthe lumen when impinging thereon. This, in turn, prevents theundesirable creation of material flecks dug by the needle.

After locating the port 1010 via through-skin palpation or imaging, aclinician uses the catheter-bearing needle 42 to pierce a skin surface44 and an upper wall of the port arm 1014, the latter including aneedle-penetrable material. The needle 42 is inserted until a distal tip42A thereof impinges on a lower wall 1024 of the arm 1014, which isformed of a needle-impenetrable material.

The needle 42 can then be proximally backed out a small distance, andthe catheter 40 advanced over the needle such that the catheter bendsand advances into the lumen 1020 of the arm 1014. Once the distal end40A of the catheter 40 is in fluid communication with the arm lumen1020, further advancement can cease and fluid transfer through thecatheter 40 and port 1010 can commence, including infusion and/oraspiration through the stem 24. Once fluid transfer is completed, thecatheter 40 can be withdrawn proximally and then withdrawn through thesurface 44 of the skin and out of the patient.

Advantageously, the port 1010 provides a relatively large area withwhich a clinician can access the port while maintaining a low profile.This allows a clinician to access the dialysis device at differentpositions during the course of multiple dialysis treatments, byinserting the needle in different locations along the arms 1014.

Reference is now made to FIGS. 35A-35J, which show various details of avascular access dialysis device, generally designated at 1110, inaccordance with one embodiment. The port 1110 is configured to besurgically implanted under the skin of a patient, and includes a portbody 1112 fluidly connected at a distal end with an in-dwelling,multi-lumen catheter 1002 disposed within the vasculature of a patient.The port body 1112 defines an elongate chamber 1114, such as a first andsecond elongate chamber 1114A, 1114B. Each chamber is in fluidcommunication with a lumen of the in-dwelling catheter 1002 by way ofconduit 1118, defined in port body 1112, which extends from chamber 1114to a fluid outlet of stem 1124.

Each elongate chamber 1114 can extend longitudinally in a side by sidearrangement. In an embodiment, as shown in FIG. 35F, each elongatechamber 1114 can be arranged in tandem such that one is more proximalthan the other, as will be discussed in more detail herein. A lowersurface of each chamber 1114 can be shaped as an elongate funnel shapeso as to direct a needle impinging thereon towards an inlet 1116 ofconduit 1118. In an embodiment, the chamber defines a substantially flator even lower surface extending along the longitudinal axis. In anembodiment, the chamber defines a U-shaped cross sectional shape asshown in FIG. 35C.

Each chamber 1114 includes a septum 1140, formed of a self-sealing,needle-penetrating material, such as silicone. The port 1110 includes aneedle guide 1142 disposed either above or below the septum 1140. Theneedle guide 1142 can be formed of a needle impenetrable material. In anembodiment, the needle guide 1142 can be formed either as a separatepiece from that of port body 1112 or formed monolithically therewith. Inan embodiment, the needle guide 1142 be formed as a separate piece fromthat of the septum 1140 and disposed either above or below the septum1140. In an embodiment, the septum 1140 is overmolded onto the needleguide 1142 such that the needle guide is disposed within the septum1140. In an embodiment, the needle guide 1142 includes a rail thatlongitudinally bisects the septum and laterally divide the septum into aplurality of distinct access areas, or openings.

The needle guide 1142 can guide the clinician to penetrate the septum atdifferent positions, thereby avoiding repeated needle penetrations beingconcentrated at a single locus. The elongate wells 1114 and associatedsepta, provide a larger area with which to access the port while alsomaintaining a slim overall profile. The needle guide 1142 can guide aclinician to access the port at a different position, thus promotingtissue healing. For example, dialysis is performed every 2-3 days, theclinician can access the device at a first position 1144A proximate theproximal end of the needle guide 1142. During subsequent dialysistreatments, the clinician can use the needle guide 1142 to directsubsequent access points, or openings, at increasingly distal positionsfrom the first 1144A, such as position 1144B. Accordingly, subsequentaccess points can migrate distally until the most distal positon isreached 1144N. At which point the skin adjacent a first access point1144A will have had a chance to heal and the clinician can re-access theinitial access point 1144A. Further, the width of the wells 1114 andassociated septa 1140 can allow some variation in needle access within agiven position 1144 so that the septum is not traversed in exactly thesame position each time, thus improving septum longevity.

In an embodiment, as shown in FIGS. 35D-I, each elongate chamber 1114can be arranged in tandem such that a first chamber 1114A is moreproximal than a second chamber 1114B. In such an example, the proximalmost chamber 1114A can include a conduit 1118A, defined by the port body1112, which extends past the more distal chamber 1114B and is fluidlyconnected with the stem 1124. FIG. 35F shows a first vertical cut awayview of the port 1110 where a first chamber 1114A includes a firstconduit 1118A extending through first side of the port 1110 andconnecting with a first fluid outlet 1124A at the stem 1124. FIG. 35Eshows a second vertical cut away view of the port 1110 where a secondchamber 1114B includes a second conduit 1118B extending through secondside of the port 1110 and connecting with a second fluid outlet 1124B atthe stem 1124. In an exemplary embodiment, FIG. 35H shows a horizontalcutaway view of an internal chamber 1114/conduit 1118 routing.Advantageously, the tandem configuration allows for a wider septa 1140,providing more variation in injection sites at a given position. Assuch, a particular injection locus on a septum is not degraded fromrepeated needle penetrations, thereby promoting septa longevity.

It will be appreciated that the port body 1112 can be formed of asuitable biocompatible material, as discussed herein. The port body 1112can be formed of a needle impenetrable material, optionally each chamber1114 can include a needle impenetrable material lining an inner surfacethereof, as discussed herein. As shown, port 1110 includes two wells1114 formed in a port body 1112 as a single monolithic piece, althoughit will be appreciate that any number of wells can be formed in the port1110 and fall within the scope of the present invention. In anembodiment, the port 1110 can include a single chamber 1114 formed inthe port body 1110. In an embodiment, the port 1110 can include wells1114 formed as separate structures that are each connect to a lumen of amulti-lumen catheter, or an extension leg of a bifurcated catheter. Inan embodiment, each chamber can be designed with differentcharacteristics for different purposes. For example, a first chamber canbe designed for blood withdrawal and a second chamber for blood return,or they may be reversibly separable. As in other embodiments, one sidemay be used for blood withdrawal and the other side for blood return.

Reference is now made to FIG. 36A-37E, which shows details of anindwelling catheter assembly 1200, in accordance with one embodiment.The catheter assembly 1200 includes a port 1210 fluidly connected to acatheter 1250 by way of locking member 1260. FIG. 36B shows an explodedview of the catheter assembly 1200 including the port 1210, the lockingmember 1260 and a proximal end of the catheter 1250. The port 1210includes a body 1212 that is defined by a similarly shaped first conduit1212A and second conduit 1212B. A distal end of each of the first andsecond conduits 1212A, 1212B engages a distal portion 1236B of an outershell 1236. The distal end of the outer shell 1236 includes a distalreceiving slot 1238 which engages a proximal end of a stem assembly1224. The stem assembly 1224 includes a housing 1224C which isconfigured to receive a first and second stem 1224A, B at a distal endthereof.

Each of the first and second conduits 1212A, B, outer shell portions1236A, B, and stem assembly 1224, can be press fitted into engagementwith each other. Further, the first and second conduits 1212A, 1212B,can include a metal, such as titanium. It will be appreciated that theport body 1212, or portions thereof, can include a variety of materials,including metals, thermoplastics, ceramics, etc., and can include otherjoining methods including snap-fitted, adhesive, ultrasonic or otherwelding, interference fit, etc. as discussed herein. In an embodiment,the port 1210 further includes a portion of the outer shell 1236 that isovermolded onto a portion of the port body 1212. For example, proximalportion 1236A of the outer shell 1236 is formed of a compliant material,such as silicone, or similar suitable material as discussed herein andis overmolded onto the port body 1212.

FIGS. 37A-B show further details of the port 1210 of the catheterassembly 1200. Each of the first and second conduits 1212A, 1212B definea substantially funnel-shaped receiving cup 1214 for receiving anddirecting the catheter-bearing needle 42 (FIG. 14A) to operably connectwith the port 1210 in a manner similar to that already described herein.In particular, the substantially funnel shape of each receiving cup 1214is configured to direct the catheter-bearing needle 42 impinging thereontoward an inlet port 1216 that serves as an opening for a respectiveconduit 1212. The open and shallow nature of each receiving cup 1214,angled toward the skin surface of the patient enables the receiving cupto present a large, easily accessible target for the needle whenintroduced into the skin and directed toward the subcutaneouslyimplanted access port 1210.

Each of the first and second conduits 1212A, 1212B further include avalve/seal assembly 1222, such as valve/seal assembly 1222A, 1222B. Eachvalve/seal assembly 1222 includes a seal 1232 and a valve 1234 disposedin a valve/seal housing 1220. Each valve seal housing 1220 is disposedat a distal end of the respective first and second conduits 1212A, 1212Band secured in place with a nozzle 1221, e.g. nozzle 1221A, B. A distalend of the nozzle 1221 is received within a proximal end of the outershell distal portion 1236B. Accordingly, the port body 1212, includingthe respective valve/seal assemblies 1220, nozzles, 1221 and stem 1224define lumen 1218A, 1218B that extend from an inlet port 1216A, 1216B toa respective outlet of stem 1224A, 1224B. Note that features of otherembodiments described herein, for example palpation features, indicia,septa, guide grooves, valves, seals, etc., can be included with the port1210.

FIG. 38A-38B shows details of an exemplary multi-lumen catheter 1250.The catheter 1250 includes an elongate tube extending from a proximalend to a distal end and can define at least one lumen. Although FIG. 38Bshows a dual-lumen catheter it will be appreciated that catheters withgreater or fewer lumens are contemplated to fall within the scope of thepresent invention. A proximal end 1252 is configured to fluidlycommunicate with stem assembly 1224. In an embodiment, a first stem1224A communicates with a first lumen 1254A and a second stem 1224Bcommunicates with a second lumen 1254B. —

The catheter 1250 includes an annular collar 1256 disposed proximate aproximal end which co-operates with a locking member 1260, and will bediscussed in more detail herein. The catheter 1250 also includes a cuff1258. The cuff 1258 can be made of, for example DACRON™, or similarsuitable material. The cuff 1258 serves as an ingrowth cuff to furthersecure the catheter upon implantation within the body.

Referring to FIGS. 39A-39C, the catheter assembly 1200 further includesa locking member 1260 that fits over the catheter 1250 and engages theport body 1212, securing the catheter 1250 thereto. To note, FIG. 39Cshows the stem assembly housing 1224C, locking member 1260 and catheter1250, with the first and second stems 1224A, B removed for clarity. Thelocking member 1260 includes a channel 1262 extending from a proximalend to a distal end of the locking member 1260, and is designed toreceive a catheter disposed therethrough. A circumference of the channel1262 is sized to fit snugly about a circumference of the catheter 1250.The locking member 1260 includes an annular abutment 1264 disposedtowards a distal end of the channel 1262 and extending radially inward.The annular abutment 1264 abuts against an annular collar 1256 of thecatheter and inhibits longitudinal distal movement of the catheterrelative to the locking member 1260.

The locking member 1260 includes an upper and lower portion 1266, 1268that extend proximally to define an upper and lower surface of thelocking member 1260, respectively. The upper and lower portions 1266,1268 further define openings in the left and rights sides of the lockingmember 1260. The openings extend proximally, from a distal end, to apoint that is proximal of the distal end and are configured to receive aportion of the stem assembly housing 1224C.

The locking member 1260 further includes protrusions 1272 disposed at adistal end of the locking member 1260 and extend transversely inwards.Protrusions 1272A, 1272B extend transversely downwards from a distal endof the upper portion 1266, and protrusions 1272C, 1272D extendtransversely upwards from a distal end of the lower portion 1268. Theprotrusions 1272 co-operate with slots 1274 disposed in an upper andlower surface of the port housing 1224C, such that each protrusion1272A-D engages a corresponding slot 1274A-D.

The locking member 1260 includes a resilient material such that an upperand lower portions 1266, 1268 are able to flex slightly. Accordingly, asthe locking member 1260 is urged distally to engage the housing 1224Cthe upper and lower portions 1266, 1268 flex outward allowing thehousing 1224C to be received within the space defined by the upper andlower portions 1266, 1268 of the connector. Further, the protrusions1272 can include a chamfer to facilitate sliding over a distal portionof the housing 1224C and engage the slots 1274. Accordingly, the lockingmember can securely engage the housing 1224C and can align the catheter1250 with the stem 1224.

Advantageously, the catheter assembly 1200 provides a modularconstruction where individual components can be press fitted or snapfitted into place, although other methods of attaching are alsocontemplated. Accordingly, this facilitates manufacture and assemblytogether with improved associated costs. Moreover, being formed of amodular construction allows individual components to be modified andchanged to suit different specifications with minimal interference tothe manufacturing process. For example, port body 1212 can be configuredto receive different gauge needles, catheters, or the like by exchangingthe body conduits 1212A, 1212B, nozzles, 1221, valve assemblies 1222, orthe like. Similarly, the catheter 1250 and stem assemblies 1224 can beeasily exchanged for catheters of different characteristics such asdifferent gauges, thicknesses, physical characteristics (e.g. materials,durometers), lumens characteristics, tip characteristics, or the like.

The port 1210, locking member 1260 and catheter 1250 can also co-operateto define a substantially smooth outer profile to the catheter system1200. This advantageously facilitates implantation within a tissuepocket and reduces patient discomfort once implanted. Further, a smoothouter profile allows any palpation features disposed there on to be morepronounced and therefore more easily discernable by a clinician.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A low-profile access port, comprising: a bodyincluding: a first set of receiving cups; a first set of inlet ports,each receiving cup of the first set of receiving cups in fluidcommunication with an inlet port of the first set of inlet ports, eachreceiving cup concavely shaped to direct an impinging needle toward theinlet port; and a first conduit in fluid communication with each inletport of the first set of inlet ports, the first conduit extending fromthe first set of inlet ports to a first outlet of a port stem; and acatheter in fluid communication with the first outlet.
 2. Thelow-profile access port according to claim 1, wherein the body furtherincludes a second set of receiving cups and a second set of inlet ports,each receiving cup of the second set of receiving cups in fluidcommunication with an inlet port of the second set of inlet ports, and asecond conduit in fluid communication with each inlet port of the secondset of inlet ports, the second conduit extending from the second set ofinlet ports to a second outlet of the port stem.
 3. The low-profileaccess port according to claim 2, wherein the first set of receivingcups is proximal to the second set of receiving cups.
 4. The low-profileaccess port according to claim 1, wherein a perimeter of each receivingcup of the first set of receiving cups lies in a plane, and wherein theplane of the perimeter of each receiving cup is angled with respect toone another.
 5. The low-profile access port according to claim 1,wherein a perimeter of each receiving cup of the first set of receivingcups lies in a plane, and wherein the plane of the perimeter of eachreceiving cup is co-planar with respect to one another.
 6. Thelow-profile access port according to claim 1, wherein a perimeter ofeach receiving cup of the first set of receiving cups includes a cutout,the cutout between adjacent receiving cups providing communicationtherebetween.
 7. A dialysis catheter assembly, comprising: a catheterhaving a first lumen and a second lumen; a bifurcation hub having adistal end in communication with a proximal end of the catheter; a firstextension leg and a second extension leg connected to a distal end ofthe bifurcation hub, the first extension leg in fluid communication withthe first lumen, the second extension leg in fluid communication withthe second lumen; and a first port including a first receiving cupdefining a first perimeter substantially parallel to the skin surfacefollowing implantation of the dialysis catheter assembly, the first portincluding a first outlet in fluid communication with the first receivingcup, the first outlet in fluid communication with the first extensionleg; and a second port separated from the first port, the second portincluding a second receiving cup defining a second perimetersubstantially parallel to the skin surface following implantation of thedialysis catheter assembly, the second port including a second outlet influid communication with the second receiving cup, the second outlet influid communication with the second extension leg.
 8. The dialysiscatheter assembly according to claim 7, wherein the first receiving cupincludes a first septum covering the first perimeter, and the secondreceiving cup includes a second septum covering the second perimeter,the first septum and the second septum providing a continuous outerprofile to the first port and the second port.
 9. A subcutaneousdialysis port, comprising: a catheter having a first lumen and a secondlumen; a bifurcation hub having a distal end in communication with aproximal end of the catheter; a first elongate arm and a second elongatearm connected to a distal end of the bifurcation hub, the first elongatearm in fluid communication with the first lumen, the second elongate armin fluid communication with the second lumen, each of the first elongatearm and the second elongate arm including a needle penetrable portion inan upper wall thereof.
 10. The subcutaneous dialysis port according toclaim 9, wherein a lower wall of the first elongate arm and the secondelongate arm are formed of a compliant material that allows the firstand second elongate arm to conform to a contour of a patient's body. 11.The subcutaneous dialysis port according to claim 9, wherein the firstelongate arm and the second elongate arm each include an end capdisposed at the proximal end thereof, each end cap including at leastone of a palpation feature and an indicia, the indicia observable undera suitable imaging modality.
 12. The subcutaneous dialysis portaccording to claim 11, wherein the at least one of the palpation featureand the indicia indicating a flow direction to a user.
 13. Thesubcutaneous dialysis port according to claim 9, wherein the needlepenetrable portion includes a self-sealing silicone material.
 14. Thesubcutaneous dialysis port according to claim 9, wherein a lower wall ofthe first elongate arm and the second elongate arm are formed of aneedle impenetrable material.
 15. A port assembly, comprising: a firstconduit including a first receiving cup at a proximal end and a firstnozzle at a distal end, wherein a first valve assembly is disposedbetween the first receiving cup and the first nozzle; a second conduitincluding a second receiving cup at a proximal end and a second nozzleat a distal end, wherein a second valve assembly is disposed between thesecond receiving cup and the second nozzle; and an outer shellsurrounding the first conduit and the second conduit, the outer shellincluding a proximal portion surrounding the first receiving cup and thesecond receiving cup, and the distal portion surrounding the firstnozzle and the second nozzle, the proximal portion, the distal portion,the first conduit, and the second conduit connected via press fitengagement.
 16. The port assembly according to claim 15, wherein thedistal portion of the outer shell includes a distal receiving slotdesigned to receive a stem assembly.
 17. The port assembly according toclaim 16, wherein the stem assembly includes a housing having a proximalend designed for insertion into the distal receiving slot, and whereinthe stem assembly is connected to the distal portion of the outer shellvia press fit engagement.
 18. The port assembly according to claim 17,wherein the stem assembly includes a first stem and a second stemextending from a distal end of the housing, the first stem in fluidcommunication with the first receiving cup, and the second stem in fluidcommunication with the second receiving cup.
 19. The port assemblyaccording to claim 18, further comprising a catheter including a firstlumen designed for insertion over the first stem, a second lumendesigned for insertion over the second stem, and a locking memberdesigned to couple the stem assembly to the catheter.
 20. The portassembly according to claim 19, wherein the stem assembly includes afirst slot on an upper portion and a second slot on a lower portion, andwherein the locking member includes a first protrusion designed tosnap-fit in the first slot, and a second protrusion designed to snap-fitin the second slot.
 21. The port assembly according to claim 20, whereinthe outer shell, the housing, and the locking member together provide asmooth continuous outer surface.